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Data Integrity, GDP and Electronic Data Governance: 2-Day In-Person Seminar

ComplianceOnline.com MetricStream

Thursday, July 5, 2018 at 8:30 AM - Friday, July 6, 2018 at 4:30 PM (Singapore Standard Time Singapore Time)

Data Integrity, GDP and Electronic Data Governance:...

Ticket Information

Ticket Type Sales End Price Fee Quantity
Early Bird
Early Bird Prices: (Registrations till May 25, 2018 - $1299) (Registrations till June 10, 2018 - $1499) (Registrations after June 10, 2018 - $1699)
Jun 30, 2018 $1,499.00 $61.43

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Event Details

Data Integrity, Good Documentation Practices and Electronic Data Governance: 2-Day In-Person Seminar

5th & 6th of July 2018 at Hilton Singapore by Warford Reaney, Consultant and Mentor.

 

Course Description:

Three interactive modules that tackle the requirements and the discipline needed to consistently manually document and electronically record the manufacturing & testing of APIs, Drug Formulations, Biosimilars and Vaccines:

 

DATA INTEGRITY MEANS
Manual Entries: "If you didn’t write it down per ALCOA...
Electronic Transactions: "If it wasn’t validated per Part 11 with intact audit trails...

it didn't happen"

  

  • FDA / EMA: Expectations for Data Integrity Ethics, Law and Transparency
  • Data Integrity Reality: Detect; Panic; Investigate; Report and Repair
  • Documentation Best Practices
  • Electronic Data Governance in the GMP Environment


Learning Objectives: 

  • Regulatory Expectations and Laws regarding Data Integrity and Electronic Data Governance
  • How to handle Data Integrity challenges of detection, investigation, regulatory response and CAPA
  • Case Studies that describe real life examples of how companies have handled Data Integrity Issues and how the regulators reacted
  • Best Practices for creating GMP appropriate Documentation
  • How to encourage GMP Documentation discipline on the shop floor, warehouse and labs
  • How the interactive role of the quality systems and plant management can bring about a culture of good GMP documentation
  • Electronic Data Governance: Regulatory expectations; what documents / policies / procedures should be in place; how to define the GMP boundaries around automated systems; role of Quality Assurance with automated systems; what to do and how to investigate if there are electronic data integrity problems.

 

Who will Benefit:

 

  • QA Personnel
  • QA-IT Personnel
  • IPQA Personnel
  • QC Personnel
  • Manufacturing Personnel
  • Engineering Personnel
  • Warehouse / Material Management Personnel
  • GMP Management Personnel
  • R&D Personnel involved with Tech Transfer
  • GMP API Personnel
  • Non-GMP Intermediates Personnel
  • CRO / CRAMS Personnel
  • HR Personnel

 

Below is the seminar link to view more details and download brochure: 
https://www.complianceonline.com/fda-data-integrity-good-documentation-practices-gdp-gmp-insspection-seminar-80565SEM

Registration Price is only $1,299, with significant discounts available for more than 1 attendee. Use Coupon Code: 351360 to avail flat 5% off. 

Budget constraint? I have special corporate discounts available, for more information please write to Mohammad.Irshad@ComplianceOnline.Com or call +1 650-332-0381.


Have questions about Data Integrity, GDP and Electronic Data Governance: 2-Day In-Person Seminar? Contact ComplianceOnline.com MetricStream

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When & Where


Hilton Singapore
581 Orchard Rd
Singapore, 238883
Singapore

Thursday, July 5, 2018 at 8:30 AM - Friday, July 6, 2018 at 4:30 PM (Singapore Standard Time Singapore Time)


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Organizer

ComplianceOnline.com MetricStream

At ComplianceOnline, we are focused on:

Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.

Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.

Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.

Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

  Contact the Organizer

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